Carpal Tunnel SyndromeNCT06321276
Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Carpal Tunnel Syndrome
A study testing extracorporeal shockwave therapy in people with Carpal Tunnel Syndrome, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18-65 years with carpal tunnel syndrome diagnosed clinically and by EMG
- Patients who can correctly understand what is stated in the patient information form and who can cooperate
- Patients who consent to participate in the study according to the informed consent form will be included in the study.
Who cannot join
- Cervical radiculopathy
- Polyneuropathy
- Brachial plexopathy
- Use of systemic corticosteroids or local corticosteroid injections
- History of fracture and trauma in the forearm and wrist on the treated side
- Inflammatory rheumatic disease
Show all 12Show fewer
- Pregnant and lactating patients
- Systemic diseases such as renal failure, peptic ulcer, DM, hypothyroidism, coagulation disorder
- Patients undergoing carpal tunnel syndrome surgery
- People with pacemakers
- Thoracic outlet syndrome
- Tenar atrophy, severe carpal tunnel syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirsehir Ahi Evran University
Kırşehir, Kırşehir, 40100
About this study
Official title: Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Patients With Carpal Tunnel Syndrom a Randomized Controlled Study
Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined.
Read the detailed description
The study included 72 patients with CTS aged 18-65 years who applied to Kırşehir Ahi Evran University Training and Research Hospital Physical Therapy and Rehabilitation Center.
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy. In CTS, the median nerve is compressed within the carpal canal, about 1 to 2 cm beyond the distal wrist crease. It is more common in women and is typically more severe in the dominant hand but is often bilateral. Repetitive hand and wrist movements, such as using a keyboard or vibrating tools, have been associated with CTS. Medical conditions associated with CTS include diabetes, hypothyroidism and RA, as well as obesity and pregnancy. Rarely, CTS may be caused by a mass lesion in the wrist, such as a ganglion cyst or neurofibroma, or may be associated with acute trauma to the wrist. The vast majority of CTS cases are idiopathic.
CTS treatment is divided into conservative and surgical treatment. Conservative treatment methods are recommended in mild and moderate CTS patients, while surgical treatment is recommended in severe cases.
Extracorporeal Shock Wave Therapy is one of the physical therapy applications used in the treatment of Carpal Tunnel. The effectiveness of ESWT in the treatment of CTS will be examined
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- extracorporeal shockwave therapy
- Keywords
- rehabilitation, extracorporeal shock wave therapy, physical therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shockwave therapyDevice
Extracorporeal shock wave therapy (ESWT) is a non-invasive procedure that uses single-pulse acoustic waves generated outside the body and focused on a specific area of the body. Shock waves promote axonal regeneration of peripheral nerves through various molecular reactions. Although the anti-nociceptive mechanisms of ESWT have not yet been elucidated, ESWT may produce analgesia through biochemical changes in the nerve fiber itself and reduce inflammation of soft tissues.
| Study group | Role | What they receive |
|---|---|---|
| two thousand pulse ESWT Group | Active comparator | ESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 2000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy) Receives: Device: extracorporeal shockwave therapy |
| one thousand pulse ESWT Group | Active comparator | ESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 1000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy) Receives: Device: extracorporeal shockwave therapy |
| Conventional Control Group | No intervention | The patient will receive conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises as directed by the physiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Measured: 0. week , 4. week , 12. week
Boston Carpal Tunnel Syndrome Questionnaire
It assesses the severity of symptoms and functional status. The symptom severity scale (SSS) assesses symptoms according to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice answers scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the average of the scores for the 11 individual items.
Functional status scale (FSS) assesses the impact of CTS on daily life. The scale consists of eight multiple-choice questions scored from 1 point (no difficulty in the activity) to 5 points (unable to do the activity at all). The total score for functional status was calculated as the average of all eight. Therefore, a higher symptom severity or functional status score indicates worse symptoms or impaired function.
Measured: 0. week, 4. week , 12. week
Secondary outcomes (3)
Hand grip strength measurement
Jamar hand dynamometer, which has high reliability and validity in many studies, will be used to measure hand grip strength. Hand grip strength will be measured in the recommended sitting position with the shoulder in adduction and neutral rotation, elbow in 90 degree flexion, forearm in midrotation and supported, and wrist in neutral. According to the test procedure, three consecutive measurements will be made for hand grip strength and the averages will be recorded in kg.
Measured: 0. week, 4. week, 12. week
Electromyoneurography (EMNG)
Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.
Measured: 0. week, 12. week
Ultrasonography
The cross-sectional area of the median nerve will be calculated by hand drawing with the existing program of the ultrasonography device. (The cross-sectional area, mm² ) The ratio of the length of the transverse diameter of the median nerve to the length of the longitudinal diameter will be used to obtain the flattening ratio (flattening ratio=FR, FR=the transverse diameter / the longitudinal diameter).
Measured: 0. week, 12. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three groups with a conventional therapy control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Dogru, Ahi Evran University Education and Research Hospital
- Investigators
- ibrahim Doğru, MD, Principal investigator, Kirsehir Ahi Evran University Physical medicine & rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321276
- Sponsor's protocol ID
- AEU-FTR-ID-01
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huisstede BM, Hoogvliet P, Franke TP, Randsdorp MS, Koes BW. Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Aug;99(8):1623-1634.e23. doi: 10.1016/j.apmr.2017.08.482. Epub 2017 Sep 20.
PubMed 28942118Kim JC, Jung SH, Lee SU, Lee SY. Effect of extracorporeal shockwave therapy on carpal tunnel syndrome: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Aug;98(33):e16870. doi: 10.1097/MD.0000000000016870.
PubMed 31415424Ozturk Durmaz H, Tuncay F, Durmaz H, Erdem HR. Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Jul 1;101(7):685-692. doi: 10.1097/PHM.0000000000001891. Epub 2021 Oct 4.
PubMed 35706121
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Patients With Carpal Tunnel Syndrom a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06321276
- Acronym / sponsor ID
- AEU-FTR-ID-01
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- rehabilitation, extracorporeal shock wave therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined.
Detailed description
The study included 72 patients with CTS aged 18-65 years who applied to Kırşehir Ahi Evran University Training and Research Hospital Physical Therapy and Rehabilitation Center.
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy. In CTS, the median nerve is compressed within the carpal canal, about 1 to 2 cm beyond the distal wrist crease. It is more common in women and is typically more severe in the dominant hand but is often bilateral. Repetitive hand and wrist movements, such as using a keyboard or vibrating tools, have been associated with CTS. Medical conditions associated with CTS include diabetes, hypothyroidism and RA, as well as obesity and pregnancy. Rarely, CTS may be caused by a mass lesion in the wrist, such as a ganglion cyst or neurofibroma, or may be associated with acute trauma to the wrist. The vast majority of CTS cases are idiopathic.
CTS treatment is divided into conservative and surgical treatment. Conservative treatment methods are recommended in mild and moderate CTS patients, while surgical treatment is recommended in severe cases.
Extracorporeal Shock Wave Therapy is one of the physical therapy applications used in the treatment of Carpal Tunnel. The effectiveness of ESWT in the treatment of CTS will be examined
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- three groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| two thousand pulse ESWT Group | Active comparator | Device: extracorporeal shockwave therapyESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 2000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy) |
| one thousand pulse ESWT Group | Active comparator | Device: extracorporeal shockwave therapyESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 1000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy) |
| Conventional Control Group | No intervention | –The patient will receive conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises as directed by the physiotherapist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged 18-65 years with carpal tunnel syndrome diagnosed clinically and by EMG
- Patients who can correctly understand what is stated in the patient information form and who can cooperate
- Patients who consent to participate in the study according to the informed consent form will be included in the study.
Key exclusion criteria (12 listed)
- Cervical radiculopathy
- Polyneuropathy
- Brachial plexopathy
- Use of systemic corticosteroids or local corticosteroid injections
- History of fracture and trauma in the forearm and wrist on the treated side
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal shockwave therapyExtracorporeal shock wave therapy (ESWT) is a non-invasive procedure that uses single-pulse acoustic waves generated outside the body and focused on a specific area of the body. Shock waves promote axonal regeneration of peripheral nerves through various molecular reactions. Although the anti-nociceptive mechanisms of ESWT have not yet been elucidated, ESWT may produce analgesia through biochemical changes in the nerve fiber itself and reduce inflammation of soft tissues. | Device | one thousand pulse ESWT Group, two thousand pulse ESWT Group |
Primary outcome
Visual analogue scale (VAS)
Time frame: 0. week , 4. week , 12. week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: 0. week, 4. week , 12. week
It assesses the severity of symptoms and functional status. The symptom severity scale (SSS) assesses symptoms according to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice answers scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the average of the scores for the 11 individual items. Functional status scale (FSS) assesses the impact of CTS on daily life. The scale consists of eight multiple-choice questions scored from 1 point (no difficulty in the activity) to 5 points (unable to do the activity at all). The total score for functional status was calculated as the average of all eight. Therefore, a higher symptom severity or functional status score indicates worse symptoms or impaired function.
3 secondary outcomes
Hand grip strength measurement
Time frame: 0. week, 4. week, 12. week
Electromyoneurography (EMNG)
Time frame: 0. week, 12. week
Ultrasonography
Time frame: 0. week, 12. week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 28942118Huisstede BM, Hoogvliet P, Franke TP, Randsdorp MS, Koes BW. Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Aug;99(8):1623-1634.e23. doi: 10.1016/j.apmr.2017.08.482. Epub 2017 Sep 20.
- Background: PubMed 31415424Kim JC, Jung SH, Lee SU, Lee SY. Effect of extracorporeal shockwave therapy on carpal tunnel syndrome: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Aug;98(33):e16870. doi: 10.1097/MD.0000000000016870.
- Background: PubMed 35706121Ozturk Durmaz H, Tuncay F, Durmaz H, Erdem HR. Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Jul 1;101(7):685-692. doi: 10.1097/PHM.0000000000001891. Epub 2021 Oct 4.
- Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled TrialsLink provided by the sponsor.
- Effect of extracorporeal shockwave therapy on carpal tunnel syndrome: A systematic review and meta-analysis of randomized controlled trialsLink provided by the sponsor.
- Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ibrahim Doğru, MD principal investigator
Kirsehir Ahi Evran University Physical medicine & rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shockwave therapy in people with Carpal Tunnel Syndrome, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 0. week , 4. week , 12. week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06321276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.